Octaplex - Prothrombin Complex Concentrate; PCC; Factors II, VII, IX and X, with Proteins C, S and Z -- Product Record

Prothrombin Complex

      Prothrombin Complex [BIO]
      Octaplex [TR]
      Factors II, VII, IX and X, with Proteins C, S and Z [SY]
      PCC [SY]
      prothrombin complex concentrate [SY]

    FDA Class:  Biologic BLA

Index Terms:

  • Product Class Index:
      antihemophilic factors
      biopharmaceutical products
      blood products
  • Biological Index:
  • Chemical Index:
      antithrombin III (AT-III)
      DEAE Sepharose
      exempt from CBER lot release requirements
      Factor IIa
      Factor IX
      Factor IX WHO International Standard
      Factor VII
      Factor X
      Factor Xa
      filamentous hemagglutinin (FHA), Bordetella pertussis
      lyophilized (freeze-dried)
      Namalva cells
      polysorbate 80 (Tween 80)
      Protein C
      Protein S
      Protein S
      tri-n-butyl phosphate (TNBP)
      viral (nano)filtration
      viral inactivation, solvent detergent
  • Source/Host/Expression System: human blood/plasma mamprimehumblood
  • Regulatory/Status Index:
      North American coral snake
      EU200 Currently Approved in EU
      UM999 Not Available/Not Marketed in US
      US000 never filed/no plans